Hallux Valgus- Radiological and Clinical Predictors for Outcome After Surgery
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|ClinicalTrials.gov Identifier: NCT04851249|
Recruitment Status : Not yet recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
|Condition or disease||Intervention/treatment|
|Hallux Valgus||Procedure: Hallux Valgus - chevron osteotomy, lapidus procedure|
Hallux valgus (HV) is the most common deformity in the adult forefoot. Characterizing and classifying HV primarily has been based on weightbearing radiographic imaging. Understanding of this pathologic process has mainly been confined to two planes, where the dominating modality of choice has been assessment by antero-posterior (AP) and lateral radiographs. From these two projections, imaging parameters have developed to define the severity of HV. With this understanding as the basis for describing the deformity, more than 140 operative techniques have been described. Although many of these techniques are of historical interest only, consistently favourable outcomes remain elusive even among more popular current techniques. HV corrective surgery is known to have mediocre results, with recurrence rate as high as 30-70%. Unsuccessful treatment of the condition is amongst the most common in the Norwegian patient injury compensation scheme (Norsk pasienterstatning, NPE). The variation in corrective techniques and the associated persistent and clinically significant rates of poor outcomes may indicate an incomplete treatment of the pathoanatomy of HV. Numerous recent publications have proved that the hallux valgus deformity should be viewed as a three-dimensional deformity. These recent studies have also pointed out new radiological parameters in AP and axial view, focusing on the multiplanar understanding of the deformity. The key challenge of the hallux valgus foot is the lack of clear guidelines for choosing the best treatment to these large group of patients. There is of today no guidelines nor consensus considering the indication for surgical treatment of the hallux valgus deformity. It is not known how much nuisance the patient should present before surgery could be worthwhile. Many studies have been made in the field of HV, but literature with the focus on comparing the surgical correction and the patient related clinical outcome is sparse and insufficient.
In this project the investigators primary aim is to investigate radiological and clinical factors that predict outcome in participants operated for hallux valgus deformity.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Hallux Valgus - Radiological and Clinical Predictors for Outcome After Surgery|
|Estimated Study Start Date :||May 1, 2021|
|Estimated Primary Completion Date :||December 1, 2026|
|Estimated Study Completion Date :||December 1, 2027|
Adult participants operated for Hallux Valgus deformity
All adult participants accepted for hallux valgus corrective surgery at østfold hospital trust (ØHT) is asked to participate in the study. The goal is to include 200-250 participants.
Procedure: Hallux Valgus - chevron osteotomy, lapidus procedure
The purpose is to compare the preoperative clinical features (previous medical history, age, BMI, occupational status etc), PROMs (Manchester-Oxford Foot and ankle questionnaire, SF-36, VAS activity scale) and radiological parameters (both two and three dimensional) with the postoperative PROMs (+ likert scale) and the postoperative radiological parameters.
- Comparing the pre and postoperative Manchester-Oxford Foot Questionnaire (MOXFQ) index score in participants operated for hallux valgus deformity [ Time Frame: Participant enrollement is expected to be completed within 3-4 years time, they will be evaluated preoperatively, 6 weeks, 12 weeks and 52 weeks postoperatively ]The MOXFQ (Dawson et al., 2006) was developed to measure perceived foot-spesific functioning and health-related quality of life. The MOXFQ is supported as the current most valid, reliable and responsive foot & ankle instrument (Jia, Huang & Gagnier, 2017). It is aviable in Norwegian, but has not been validated in its translated form. The score compromises a total of 16 items. They are distributed within 3 dimensions; foot pain (5 items), walking/standing (7 items) and social interaction (4 items) where all items are scored on a 5-point Likert scale, score 0 (best) to 4 (worst). The MOXFQ index score (Morely et al., 2013) will be used as the main outcome and we define an increase of at least 15 points as a successful outcome. We plan to run multiple regression analysis with baseline parameters as well as radiological and PROM data as predictors. To accont for loss to follow-up we will include 250 patients in this study.
- Comparing the traditional and newer rotational radiological parameters with PROMs pre and postoperatively [ Time Frame: Participant enrollement is expected to be completed within 3-4 years time, patient follow-up 6, 12 and 52 weeks postoperatively. Goal of inclusion 250 patients. ]Investing the correlation between the traditional and newer rotational parameters on weighted anterior-posterior and axial radiograph of the forefoot (lateral head shape of first metatars, hardy and Clapham tibial sesamoid position, joint congruity, DMAA, IMA, HVA, metatarsal rotational angle, sesamoid rotational angle) and the PROMs (MOxFQ, SF-36, VAS activity, likert scale) pre and postoperatively
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851249
|Contact: Marius Molund, MD, PhDemail@example.com|
|Contact: Mikaela Engarås Hamre, MDfirstname.lastname@example.org|
|Study Director:||Marius Molund, MD, PhD||Head of foot and ankle department at ØHT|